Low-Intensity Pulsed Ultrasound as an Adjunctive Therapy for Bone Regeneration Following Jaw Cyst Enucleation With Curettage: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 29
- 主要终点
- cyst cavity volume reduction
研究概览
简要总结
This study tested whether low-intensity pulsed ultrasound (LIPUS) could help patients recover better after surgery to remove jaw cysts.
A total of 29 patients with 33 jaw cysts were included. After surgery, they were randomly assigned to two groups:
Ultrasound group (17 patients, 18 cysts): received daily LIPUS therapy for 10 days.
Control group (12 patients, 15 cysts): received the same care but with a sham (inactive) device.
The study was triple-blinded, meaning that the patients, the surgeon, and the evaluators did not know who was receiving real or sham treatment.
Researchers measured recovery in several ways:
Patient reports: pain, numbness, anxiety/depression, and oral health-related quality of life.
Clinician monitoring: checked for any side effects (like infection or burns). Imaging tests (CBCT scans): tracked how well bone healed by measuring changes in cyst cavity size (volume reduction) and new bone density.
All patients had the same type of surgery, performed by the same surgeon, and all provided written informed consent. The study followed international ethics and trial registration standards.
详细描述
This clinical trial will explore whether a special type of ultrasound treatment, called low-intensity pulsed ultrasound (LIPUS), can improve recovery after surgery to remove cysts in the jaw. Jaw cysts are fluid-filled sacs that can weaken the jawbone, cause swelling, and sometimes lead to pain or numbness. The standard treatment is surgical removal of the cyst, but healing can take a long time, and patients may continue to experience discomfort or reduced quality of life.
To investigate a possible solution, researchers will enroll 29 patients with a total of 33 jaw cysts. After their cysts are surgically removed, patients will be randomly divided into two groups:
The ultrasound group will receive 10 days of daily LIPUS therapy, beginning three days after surgery.
The control group will receive the same routine care but with a sham (inactive) device that looks and feels the same, so patients will not know if they are receiving real ultrasound.
The study will use a triple-blind design, meaning that the patients, the surgeon, and the evaluators will not know which group each patient is in. This ensures that the results are as reliable and unbiased as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Before the group's assignment, all enucleation procedures will be carried out by the same surgeon to ensure consistency in surgical techniques. Three days after the surgery, patients will be randomly allocated to one of two groups using opaque, sealed envelopes. A nurse who is uninvolved in the research will open the randomization envelopes to reveal the assigned treatments: those in the ultrasound group will receive active LIPUS therapy, whereas the control group will be given sham LIPUS therapy, using an inactive device. Throughout the study, the surgeon, participants, outcome assessors, and statistician will remain unaware of the group allocation, maintaining a triple-blind design.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years.
- •having undergone cyst enucleation with curettage.
- •postoperative histopathological confirmation of a jaw cyst.
- •willingness to complete 10 days of standardized LIPUS therapy
排除标准
- •severe psychiatric disorders impairing compliance.
- •acute infection.
- •presence of a cardiac pacemaker.
- •osteoporosis.
结局指标
主要结局
cyst cavity volume reduction
时间窗: Time Frame: Measured from baseline (before cyst enucleation) to 3 months and 6 months post-treatment.
The primary outcome measure of this trial will be cyst cavity volume reduction, assessed using cone-beam computed tomography (CBCT). Volumetric measurements of the cystic cavity (preoperative) and the residual cavity (at 3 and 6 months post-treatment) will be performed with Mimics 21.0 software (Materialise, Belgium).
Bone Density (CBCT, Relative Hounsfield Units).
时间窗: Measured at baseline (pre-surgery), 3 months, and 6 months post-treatment.
CBCT scans will quantify the mineral density of newly formed bone in the cyst site. The density will be expressed as relative Hounsfield Units (HU), using the nearest tooth's dentine as an internal reference. A relative HU value approaching 1 indicates higher bone mineralization, reflecting better bone regeneration after surgery with or without LIPUS therapy.
次要结局
- Pain Intensity (VAS, 0-10) and Numbness Intensity (scale, 0-10)(Recorded before LIPUS/sham therapy, on Day 5, Day 10, 3 months, and 6 months post-treatment.)
- Oral Health-Related Quality of Life (OHIP-14, 0-56)(Pre-treatment, Day 10, 3 months, 6 months post-treatment.)
研究者
Sadam Elayah
Dr
Sichuan University